Jupiter Wellness (as PLD) - Photocil (82301-004) - DELIST

Photocil by

Drug Labeling and Warnings

Photocil by is a Otc medication manufactured, distributed, or labeled by Jupiter Wellness, Inc., Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PHOTOCIL- dimethicone cream 
Jupiter Wellness, Inc.

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Jupiter Wellness (as PLD) - Photocil (82301-004) - DELIST

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses

• helps prevent and temporarily protects and relieves chapped or cracked skin prone to psoriasis and vitiligo.

Warnings

For external use only

This product is not a sunscreen or sunblock. Prolonged sun exposure can cause sunburn, skin damage, and cancer. Healthy (non-psoriasis or vitiligo affected) skin should be covered with clothing or protected with a sunscreen.

• When using this product do not get into eyes
• If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask doctor if

• condition worsens
• symptoms do not improve after more than 7 days

Keep out of reach of children.

Other information

• store at room temperature

Directions

• consult dermatologist prior to use
• apply as needed
• apply Photocil cream to affected skin area(s)
• allow affected area(s) of skin to receive direct exposure to daylight following application of Photocil cream for 20 minutes
• protect unaffected skin from sun exposure

Inactive ingredients

1,2-hexanediol, 2-ethylhexyl benzoate, caprylyl glycol, carbomer interpolymer type a (allyl sucrose crosslinked), cetostearyl alcohol,

dimethyl isosorbide, edetate disodium, glucosyl hesperidin, glyceryl mono-stearate, PEG-100 stearate, polyoxyl 20 cetostearyl ether,

propanediol, sesame oil, trolamine, water

561.244.7100

Carton Label

PHOTOCIL 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82301-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.6 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLUCOSYL HESPERIDIN (UNII: 432C95B6YE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPANEDIOL (UNII: 5965N8W85T)
SESAME OIL (UNII: QX10HYY4QV)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82301-004-01	1 in 1 CARTON	11/30/2021	12/31/2023
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/30/2021	12/31/2023

Labeler - Jupiter Wellness, Inc. (118320452)

Revised: 3/2024

Document Id: 14bc4bb2-33c0-0d35-e063-6394a90a76c0

34390-5

Set id: d203badb-b9d0-f64b-e053-2995a90a7f20

Version: 3

Effective Time: 20240328